FDA Enforcement
Class II
Ongoing
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Recall: Z-1264-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1264-2024
- Event ID
- 94026
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2024
- Initiation Date
- February 6, 2024
- Classification Date
- March 6, 2024
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006, United States
Description
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Reason
Potential packaging breaches of inner blister and outer sterile blister.
Code Info
Part No. 5537-G-411-E; GTIN: 07613327287691; Lot No. E97TH6; Expiration Date: 10/07/2028.
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Quantity
18 units (US); 5 units (OUS)